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Hormone Therapy

Hormone Therapy for Postpartum Depression

Phase 2
Recruiting
Led By Pedro E Martinez, M.D.
Research Sponsored by National Institute of Mental Health (NIMH)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ongoing
Awards & highlights

Study Summary

This trial is designed to study whether postpartum depression is caused by the sudden withdrawal of estrogen and progesterone.

Who is the study for?
This trial is for women aged 18-50 who have experienced major depression or mood disorders within three months after childbirth, are in good health, and have had a stable menstrual cycle for at least three months. They should not be pregnant or breastfeeding and must have been well for at least one year without any history of severe postpartum mental health issues.Check my eligibility
What is being tested?
The study tests if hormone changes trigger postpartum depression by simulating pregnancy hormones with Estradiol and Progesterone, then suddenly stopping them. Some participants will continue the hormones longer to compare effects on mood and behavior.See study design
What are the potential side effects?
Possible side effects may include mood swings, hormonal imbalance symptoms like hot flashes or vaginal dryness, injection site reactions from hormone treatments, and general discomfort associated with abrupt hormonal withdrawal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~ongoing
This trial's timeline: 3 weeks for screening, Varies for treatment, and ongoing for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Outcome measures will include mood, behavioral, and hormonal parameters as well as response to o-CRH.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Group 2, Continued Replacement GroupActive Control2 Interventions
12 weeks of hormone addback
Group II: Group 1, Hormone and Placebo GroupPlacebo Group3 Interventions
8 weeks of hormonal addback plus 4 weeks of placebo

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)Lead Sponsor
2,777 Previous Clinical Trials
2,674,272 Total Patients Enrolled
24 Trials studying Postpartum Depression
8,043 Patients Enrolled for Postpartum Depression
Pedro E Martinez, M.D.Principal InvestigatorNational Institute of Mental Health (NIMH)
2 Previous Clinical Trials
39 Total Patients Enrolled
Peter J Schmidt, M.D.Principal InvestigatorNational Institute of Mental Health (NIMH)
13 Previous Clinical Trials
3,820 Total Patients Enrolled
2 Trials studying Postpartum Depression
80 Patients Enrolled for Postpartum Depression

Media Library

Estradiol (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00001481 — Phase 2
Postpartum Depression Research Study Groups: Group 1, Hormone and Placebo Group, Group 2, Continued Replacement Group
Postpartum Depression Clinical Trial 2023: Estradiol Highlights & Side Effects. Trial Name: NCT00001481 — Phase 2
Estradiol (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00001481 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people over the age of 40 able to participate in this trial?

"The age requirement for this clinical trial are individuals who are over 18 but under 50 years of age."

Answered by AI

How many individuals are test subjects in this clinical trial?

"Yes, the trial is still open for recruitment according to the clinicaltrials.gov website. This particular study was created on 4/26/1996 and was updated as recently as 11/4/2022. They are looking for 100 people to participate at 2 different locations."

Answered by AI

What are the risks associated with Group 2, Continued Replacement Group for patients?

"Group 2, Continued Replacement Group, is estimated to be a 2 in terms of safety. Phase 2 trials mean that while there is some safety data, there is none yet supporting efficacy."

Answered by AI

What is Group 2, Continued Replacement Group's primary purpose?

"The Continued Replacement Group, more colloquially known as Group 2, is most frequently used to help those who have not had a menstrual period in the last 6 months. Additionally, this group can also be used to treat conditions like hypoestrogenism, vasomotor symptoms related to menopause, and breast conditions."

Answered by AI

What other studies have contained a Group 2, Continued Replacement Group?

"There are currently 85 clinical trials studying Group 2, Continued Replacement Group, with 16 of them in Phase 3. While some of the trials for Group 2, Continued Replacement Group are located in Cheras, Kuala Lumpur, there are 974 other locations around the world where they are taking place."

Answered by AI

Are patient recruitment efforts ongoing for this research?

"That is correct. The clinical trial is still searching for enrollees and the listing on clinicaltrials.gov was last updated on 11/4/2022. They are looking for a total of 100 patients from 2 different medical centres."

Answered by AI
~4 spots leftby May 2025